Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
|ClinicalTrials.gov Identifier: NCT01383239|
Recruitment Status : Completed
First Posted : June 28, 2011
Last Update Posted : November 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear||Other: Immediate Postoperative Therapy Other: Delayed Physical Therapy||Not Applicable|
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Surgically repaired rotator cuff tears fail at surprisingly high rates, approaching 20-94% as determined by MRI 3, 9, 13, 20, 28, 40, 52, 58. Non-modifiable variables associated with rotator cuff repair failure include: duration of symptoms 9, 19, 39, fatty infiltration of the atrophied muscle 6, 15, 17, larger rotator cuff tears 6, 9, 19, 20, 21, 26, 39, 47, older age 9, 20, 22, 48, 55, co-morbidities 48, and workers compensation claims 2, 22, 23. Potentially modifiable variables include: tobacco use 11, 38, limited preoperative range of motion 45, and surgeon volume 48.
Two other modifiable variables are surgical technique and postoperative management. As advances in arthroscopic techniques have evolved, a variety of studies have evaluated different surgical techniques in clinical series and trials 3, 4, 20, 12, 18, 31, 36. In 2006, Park et al described the "transosseous equivalent" repair technique characterized by sutures secured medially, passed through and over the top of the rotator cuff, and then secured laterally 44. This method of repair has been shown to have better biomechanical properties and produce superior healing rates compared to other techniques in randomized clinical trials 5, 12. These data suggest this technique is currently the best available method to repair rotator cuff tears.
Postoperative management of patients who have had rotator cuff repair has received little attention in the literature, yet is likely one of the most important modifiable variables that can influence rotator cuff repair integrity. It has been argued that early physical therapy may increase failure rates of rotator cuff repair 1, 14. This has led some to recommend delaying therapy for up to 6 weeks after surgery.
Three groups have studied delaying the onset of physiotherapy in patients with full thickness rotator cuff tears. Klintberg et al 29 performed a randomized trial on patients who underwent open rotator cuff repair comparing two postoperative physical therapy protocols: a "Progressive Therapy Group" ¬ (started the day after surgery with passive range of motion and dynamic muscle activation of the rotator cuff, a sling was removed after 4 weeks and rotator cuff loading was progressive through the rehabilitation), and a "Traditional Group" (passive range of motion the day after surgery with immobilization in a sling for 6 weeks during which time no rotator cuff loading was applied). In this trial no significant differences in outcome were detected.
In contrast to this, Deutsch et al 7 reported on 70 patients who had a single row arthroscopic rotator cuff repair with simple suture configuration randomized to one of two physical therapy protocols that were different only in that the "Standard" protocol began passive forward elevation on postoperative day 7 (N=37), whereas the "Delayed" protocol began passive forward elevation after 4 weeks (N=33). At 6 months range of motion was not different, however ultrasound examination demonstrated 19% of the repairs failed in the "Standard" group, whereas only 9% failed in the "Delayed" group (p<0.05).
In a prospective cohort study presented by Accousti et al 1, 56 patients were all managed by 6 weeks of immobilization following rotator cuff repair. When immobilization was removed, 13 patients were considered "stiff" with limited motion, and 43 had "good" passive motion. By one year none of the patients were considered stiff. In the "stiff" group rotator cuff repairs failed in 30%, whereas in the group with "good" motion at six weeks 62% of repairs failed.
These data, while limited, suggest that some period of immobilization may improve healing of rotator cuff repairs. The effect of immobilization on other measures of outcome is unclear. Unfortunately none of these studies used the transosseous equivalent repair technique.
The purpose of this study is to compare two different strategies of postoperative management in patients with isolated supraspinatus rotator cuff tears repaired with a standardized "SpeedBridge" arthroscopic transosseous equivalent technique, using a disease specific validated measure of outcome (WORC index) as the primary outcome variable. The design will be a multicenter randomized trial comparing immediate to delayed physical therapy. As patient oriented outcomes frequently do not correlate with rotator cuff repair healing 50, the second aim is to study the effect of these rehabilitation paradigms on rotator cuff healing by MRI.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Active Comparator: Immediate postoperative therapy
Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay
Other: Immediate Postoperative Therapy
All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The Immediate group will began physical therapy 3-7 days postoperatively.
Active Comparator: postoperative therapy delayed for 6 weeks
Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay.
Other: Delayed Physical Therapy
All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The delayed group will began physical therapy 6 weeks postoperatively
- Score of the Western Ontario Rotator Cuff Index(WORC)12 months after surgery. [ Time Frame: 12 months ]Study the effect of delaying postoperative physical therapy on patient outcomes using a randomized controlled study design. Patients will be randomized into one of two groups: immediate postoperative therapy versus 6-week delay. The primary outcome variable will be the score of the WORC index 12 months after surgery.
- Evaluate postoperatively MR imaging 12 months after surgery. [ Time Frame: 12 months ]Identify how delaying postoperative physical therapy may improve healing of rotator cuff repairs as evaluated by postoperative MR imaging 12 months after surgery.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383239
|United States, California|
|UCSF Sports Medicine|
|San Francisco, California, United States, 94158|
|United States, Colorado|
|CU Sports Medicine|
|Boulder, Colorado, United States, 80304|
|United States, Iowa|
|University Of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Michigan|
|University of Michigan, Med Sport|
|Ann Arbor, Michigan, United States, 48106|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, Ohio|
|OSU Sports Medicine Center|
|Columbus, Ohio, United States, 43221|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, South Dakota|
|Sports Medicine & Shoulder Surgery Orthopedic Institute|
|Sioux Falls, South Dakota, United States, 57117|
|United States, Tennessee|
|Shoulder and Elbow Institute of Knoxville|
|Knoxville, Tennessee, United States, 37922|
|Principal Investigator:||John E Kuhn, MD||Vanderbilt University Medical Center|
|Principal Investigator:||Warren R Dunn, MD, MPH||Vanderbilt University Medical Center|
|Principal Investigator:||Charles Cox, MD, MPH||Vanderbilt Unversity Medical Center|